External infusion device with remote programming, bolus estimator and/or vibration alarm capabilities

ABSTRACT

An infusion system for infusing a liquid into a body includes an external infusion device and a remote commander. The external infusion device includes a housing, a receiver, a processor and an indication device. The receiver is coupled to the housing and for receiving remotely generated commands. The processor is coupled to the housing and the receiver to receive remotely generated commands and to control the external infusion device in accordance with the commands. The indication device indicates when a command has been received and indicates when the command is being utilized to control the external infusion device so that the external infusion device is capable of being concealed from view when being remotely commanded. The remote commander includes a commander housing, a keypad for transmitting commands, and a transmitter for transmitting commands to the receiver of the external infusion device.

RELATED APPLICATIONS

This is a divisional application of U.S. patent application Ser. No.10/062,838 filed on Jan. 31, 2002, which is a divisional of U.S. patentapplication Ser. No. 09/466,006 filed on Dec. 17, 1999 now U.S. Pat. No.6,551,276, which is a continuation application of U.S. patentapplication Ser. No. 09/334,858 filed Jun. 16, 1999 now U.S. Pat No.6,554,798, which claims priority on U.S. Provisional Patent ApplicationSer. No. 60/096,994 filed Aug. 18, 1998.

FIELD OF THE INVENTION

This invention relates to external infusion devices and, in particularembodiments, to a medication infusion device that includes thecapability to be remotely controlled, a bolus estimator to determine thedosage to be administered by the infusion device, and a vibration alarm.

BACKGROUND OF THE INVENTION

Insulin must be provided to people with Type I and many with Type IIdiabetes. Traditionally, since it cannot be taken orally, insulin hasbeen injected with a syringe. More Recently, use of external infusionpump therapy has been increasing, especially for delivering insulin fordiabetics using devices worn on a belt, in a pocket, or the like, withthe insulin delivered via a catheter with a percutaneous needle orcannula placed in the subcutaneous tissue. For example, as of 1995, lessthan 5% of Type I diabetics in the United States were using pumptherapy. There are now about 7% of the currently over 900,000 Type Idiabetics in the U.S. using insulin pump therapy, and the percentage isnow growing at an absolute rate of over 2% each year. Moreover, thenumber of Type I diabetics is growing at 3% or more per year. Inaddition, growing numbers of insulin using Type II diabetics are alsousing external insulin infusion pumps. Physicians have recognized thatcontinuous infusion provides greater control of a diabetic's condition,and are also increasingly prescribing it for patients. In addition,medication pump therapy is becoming more important for the treatment andcontrol of other medical conditions, such as pulmonary hypertension, HIVand cancer. Although offering control, pump therapy can suffer fromseveral complications that make use of a pump less desirable for theuser.

One drawback is the inability to conceal an external infusion pump andcatheter tubing from view. Many users desire to hide the external pumpunder clothing so as not to seem different from normal people. However,this is inconvenient or impractical, especially for diseases such asdiabetes, since a user must have ready access to the external pump formonitoring or administering extra amounts of medication (i.e., bolusesduring the course of the day). If a user has concealed the externalpump, the user must partially undress or carefully maneuver the externalpump to a location that permits access to the display and keypad.

A further drawback is the inability to limit the access of the user tocertain capabilities. For instance, the user should have access to thekeypad so that the user can change the values and parameters of dailypump operation. However, there may be certain parameters that the usershould not have access to. This can be especially important, when thepump is being used by children or the elderly. However, if access isvery limited, a user may even have to go to the factory and/or to thephysician to have the parameters changed.

Another drawback for diabetic pump users, in particular, is thedetermination of the amount of bolus insulin to be delivered for a mealso as to avoid high blood sugars that would otherwise be caused by themeal. This can be a difficult calculation using formulas andapproximations that have several variables that must be measured andcalculated. Often, it is easier, but not the best for control, for theuser to simply guess what they need rather than to calculate the actualamount of the bolus needed to adequately cover the carbohydrates beingconsumed. However, in worse case scenarios, guessing can lead to underor overdosing of medication, sometimes with dire consequences.

Another drawback to using an infusion pump, is the step of priming theexternal infusion pump to remove gas bubbles in the reservoir and/ortubing. The user must first manually shake the reservoir to move anybubbles to the distal end of the reservoir. Then the user must carefullyexpel the bubbles through the tubing. However, unless all bubbles aremoved to the distal end of the reservoir, the user will have to expel alarger amount of medication, which can be wasteful, and very costly forspecial types of medications, such as those used in HIV and cancertreatment. Improved methods of priming the external infusion pump areneeded.

SUMMARY OF THE DISCLOSURE

It is an object of an embodiment of the present invention to provide animproved external infusion device, which obviates for practicalpurposes, the above mentioned limitations.

According to an embodiment of the invention, an external infusion devicefor infusion of a liquid into a body includes a housing, a receiver, aprocessor and indication device. The receiver is coupled to the housingfor receiving remotely generated commands. The processor is coupled tothe housing and the receiver to receive remotely generated commands andto control the external infusion device in accordance with the commands.The indication device indicates when a command has been received andindicates when the command is being utilized to control the externalinfusion device. In this way, the external infusion device can beoperated when concealed from view by being remotely commanded.

Further embodiments include a memory for storing programs, and thereceiver is capable of receiving software updates and facilitatingremote programming of external infusion device capabilities. Inaddition, the memory may store patient infusion history and pumpactivity. Also, the remotely generated commands may be capable ofprogramming and activating an audio (or vibratory) bolus delivery of theliquid by the external infusion device, a temporary basal rate deliveryof the liquid by the external infusion device, of suspending delivery ofthe liquid by the external infusion device, an extended bolus (such as asquare wave bolus or profiled bolus) delivery of the liquid by theexternal infusion device, and a dual wave bolus delivery of the liquidby the external infusion device.

In particular embodiments, an infusion system for infusing a liquid intoa body includes an external infusion device and a remote commander. Theexternal infusion device includes a housing, a receiver, a processor andan indication device. The receiver is coupled to the housing forreceiving remotely generated commands. The processor is coupled to thehousing and the receiver to receive remotely generated commands tocontrol the external infusion device in accordance with the commands.The indication device indicates when a command has been received andindicates when the command is being utilized to control the externalinfusion device so that the external infusion device is capable of beingconcealed from view when being remotely commanded. The remote commanderincludes a commander housing, a keypad for transmitting commands, and atransmitter for transmitting commands to the receiver of the externalinfusion device.

In particular embodiments, the remote commander is sized to fit on a keyring. Also, the remote commander may use RF frequencies, opticalfrequencies, IR frequencies, ultrasonic frequencies, magnetic effects,or the like, to transmit remote commands to the external infusiondevice. In addition, the remote commander is capable of providing remotecommands at a distance greater than 1 inch. Furthermore, the processorof the external infusion device has a unique identification code, andthe remote commander includes the capability to read and learn theunique identification code of the external infusion device.Alternatively, the user can program in the unique identification code.The remote commander and the external infusion device use a uniqueidentification code to substantially avoid interference with otherexternal infusion devices.

In still other embodiments, the remote commander includes a mode thatpermits physician controlled programming of specific capabilities of theexternal infusion device to the exclusion of the user, and the remotecommander may also include a link to a computer to allow programming toinitiate or alter available capabilities of the external infusiondevice. Also, the external infusion device may include a memory forstoring programs, and the receiver is capable of receiving softwareupdates and facilitating remote programming of external infusion devicecapabilities. In addition, the memory may store patient infusion historyand pump activity. Finally, the remote commander may be capable ofreceiving data from another medical device and providing the receiveddata to the external infusion device and/or remotely commanding andcontrolling another medical device. Other embodiments of the remotecommander may also display the data.

In further preferred embodiments, an external infusion device forinfusion of a liquid into a body includes a housing, a processor, abolus estimator and an indication device. The bolus estimator used inconjunction with the processor and externally supplied values willestimate an amount of liquid to be infused based upon an estimate of amaterial to be taken in by the body. The indication device is used toindicate when an amount of fluid to be infused has been estimated. Inaddition, the bolus estimator includes the capability to estimate acorrection bolus based upon a current characteristic value and a targetcharacteristic value and/or a liquid sensitivity that is used todetermine the amount of liquid to be infused so as to estimate thecorrection bolus. Further, embodiments of the bolus estimator include alockout to prevent the calculation of a bolus for a predetermined periodof time after a bolus has been estimated by the bolus estimator. Otherembodiments include a duration factor to account for how long apreviously infused amount of liquid will remain active in the body, andto adjust the estimate accordingly. In preferred embodiments, the liquidto be infused is insulin, and the material to be taken in iscarbohydrates. Also, codes representing the carbohydrate levels ofspecific foods or meals may be used as the externally supplied values.

In yet another embodiment, an external infusion device for infusion of aliquid into a body includes a housing containing a reservoir, aprocessor and a vibration device. The processor is coupled to thehousing. The vibration device is used in conjunction with the processorto provide an alarm, and to generate sufficient vibration to assist inremoving gas bubbles from the fluid in the reservoir during priming ofthe external infusion device. In further embodiments, the vibrationdevice is used to agitate the fluid in the reservoir in between periodicdeliveries of the fluid by the external infusion device and/or duringdelivery of the fluid by the external infusion device.

In other embodiments, an external infusion device for infusion of aliquid into a body includes a housing containing a reservoir, aprocessor, an audible alarm and a vibration device. The processor iscoupled to the housing, and the audible alarm. The vibration device isused in conjunction with the processor and the audible alarm to providean alarm. In further embodiments, the vibration device is also used toagitate the fluid in the reservoir in between periodic deliveries of thefluid by the external infusion device and/or during delivery of thefluid by the external infusion device. In particular embodiments, theprocessor selects to activate one of the audible alarm and vibrationalarm independently of the unselected alarm.

In still yet another embodiment, an external infusion device forinfusion of a liquid into a body includes a housing, a processor, akeypad and an indication device. The processor is coupled to thehousing, and the keypad is coupled to the housing and used inconjunction with the processor to determine an estimate of remainingbattery power. The indication device indicates an estimate of remainingbattery power.

In still further embodiments, an external infusion device for infusionof a liquid into a body includes a housing, a processor, a memory, akeypad and an indication device. The processor is coupled to thehousing, and the memory is coupled to and used in conjunction with theprocessor to store at least two personal delivery patterns. The keypadis also coupled to the housing and used in conjunction with theprocessor to select one of the at least two personal delivery patterns,and the indication device indicates the selected personal deliverypattern. In preferred embodiments, the processor controls the externalinfusion device in accordance with the selected one of the at least twopersonal delivery patterns.

In further embodiments, an external infusion device for infusion of aliquid into a body includes a housing, a processor, a memory, a keypadand an indication device. The processor is coupled to the housing, andthe memory is coupled to and used in conjunction with the processor tostore at least two basal rate profiles. The keypad is also coupled tothe housing and used in conjunction with the processor to program the atleast two basal rate profiles, and the indication device indicates thebasal rate profile during programming. In preferred embodiments, theprocessor controls the external infusion device in accordance with theprogrammed at least basal rate profiles.

In yet further embodiments, an external infusion device for infusion ofa liquid into a body includes a housing, a processor, a memory, a keypadand an indication device. The processor is coupled to the housing, andthe memory is coupled to and used in conjunction with the processor tostore at least two bolus types. The keypad is also coupled to thehousing and used in conjunction with the processor to select one of theat least two bolus types, and the indication device indicates theselected bolus type. In preferred embodiments, the processor controlsthe external infusion device in accordance with the selected one of theit least two bolus types.

In yet still further embodiments, an external infusion device forinfusion of a liquid into a body includes a housing, a receiver,processor, memory and an indication device. The receiver is coupled tothe housing for receiving remotely generated commands. The processor iscoupled to the housing and the memory device. The memory is used inconjunction with the processor to store at least two personal deliverypatterns, and the processor is coupled to the receiver to receive theremotely generated commands and to control the external infusion devicein accordance with the commands to select one of the at least twopersonal delivery patters. The indication device is used to indicate theselected personal delivery pattern and when a command has been receivedto control the external infusion device in accordance with the selectedpersonal delivery pattern such that the external infusion device iscapable of being concealed from view when being remotely commanded.Also, the processor controls the external infusion device in accordancewith the selected one of the at least two personal delivery patterns.

Other features and advantages of the invention will become apparent fromthe following detailed description, taken in conjunction with theaccompanying drawings which illustrate, by way of example, variousfeatures of embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

A detailed description of embodiments of the invention will be made withreference to the accompanying drawings, wherein like numerals designatecorresponding parts in the several figures.

FIG. 1 is a simplified block diagram of an external infusion device andsystem in accordance with an embodiment of the present invention.

FIG. 2 is a perspective view of an external infusion device and systemin accordance with an embodiment of the present invention.

FIG. 3 is a top perspective view of an RF programmer in accordance withan embodiment of the present invention.

FIG. 4 is a top perspective view of a remote commander in accordancewith another embodiment of the present invention.

FIG. 5 is a front plan view of an LCD display for use in an embodimentof the present invention.

FIG. 6 is a table of Setup II options used on external infusion devicesin accordance with embodiments of the present invention.

FIG. 7 is a flow diagram illustrating the steps used to set a bolus withand without the carbohydrate estimator in accordance with embodiments ofthe present invention.

FIGS. 8( a) and 8(b) are flow diagrams illustrating the steps used toaccess the features of the setup II menu options shown in FIG. 6.

FIG. 9 is a table of the main menu options used on external infusiondevices in accordance with embodiments of the present invention.

FIG. 10 is a table of Setup I menu options used on external infusiondevices in accordance with embodiments of the present invention.

FIG. 11 is a flow diagram illustrating the steps used to access the mainmenu options shown in FIG. 9.

FIG. 12 is a flow diagram illustrating the steps used to access thefeatures of the setup I menu options shown in FIG. 10.

FIG. 13 is a graph showing units delivered versus expected days ofoperation on a set of batteries.

FIG. 14 is a chart illustrating factory default setting used byembodiments of the present invention.

FIG. 15 is a simplified diagram of an external infusion device andsystem in accordance with another embodiment of the present invention.

FIG. 16 is a simplified block diagram of an external infusion device andsystem in accordance with still another embodiment of the presentinvention.

FIG. 17 is a simplified block diagram of an external infusion device andsystem in accordance with yet another embodiment of the presentinvention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

As shown in the drawings for purposes of illustration, the invention isembodied in an external infusion device for infusion of a liquid, suchas medication, chemicals, enzymes, antigens, hormones, vitamins or thelike, into a body of a user. In preferred embodiments of the presentinvention, the external infusion device is an external infusion pump,which includes an RF programming capability, a carbohydrate (or bolus)estimation capability and/or vibration alarm capability. Particularembodiments are directed towards use in humans; however, in alternativeembodiments, the external infusion devices may be used in animals.

As illustrated in FIG. 1, preferred embodiments of the external infusiondevice 10 include a remote RF programmer 12, a carbohydrate (or bolus)estimator 14 and/or a vibration alarm 16. The RF programmer 12 andcarbohydrate estimator 14 communicate with a processor 18 contained in ahousing 20 of the external infusion device 10. The processor 18 is usedto run programs and control the external infusion device 10, and isconnected to an internal memory device 22 that stores programs,historical data, user defined information and parameters. In preferredembodiments, the memory device is a Flash memory and SRAM; however, inalternative embodiments, the memory device 22 may include other memorystorage devices such as ROM, DRAM, RAM, EPROM, dynamic storage such asother flash memory, energy efficient hard-drive, or the like. Inpreferred embodiments, the external infusion device 10 is an externalinfusion pump that is programmed through a keypad 24 on the housing 20or by commands received from the RF programmer 12 through atransmitter/receiver 26. Feedback from the external infusion device 10on status or programming changes are displayed on an LCD 28 and/oraudibly through a speaker 30. In alternative embodiments, the keypad 24may be omitted and the LCD 28 may be used as a touch screen input deviceor the keypad 24 may utilize more keys or different key arrangementsthen those illustrated in the figures. The processor 18 is also coupledto a drive mechanism 32 that is connected to a fluid reservoir 34containing fluid that is expelled through an outlet 36 in the reservoir34 and housing 20, and then into a body of a user through tubing and aset 38. In further alternative embodiments, the keypad 24, LCD 20,speaker 24 may be omitted from the external infusion device, and allprogramming and data transfer is handled through the RF programmer 12.

Generally, as shown in FIG. 2, preferred embodiments of the externalinfusion device 10 are an external insulin pump having the capability todeliver 0 to 35 Units/hour in basal rates and up to 25.0 Units per mealbolus of U-100 Insulin. In alternative embodiments, the external pumpdelivers other concentrations of insulin, or other liquids, and may useother limits on the delivery rate.

The external infusion device 10 will also give the user the choice of anaudible alarm and/or vibration alarm 16 such as of a warning that isindicative of a low reservoir situation or low battery or somemalfunction of the system, such as an occlusion of the outlet thatrestricts the delivery of the fluid. Alarms may start out at a low leveland escalate until acknowledged by the user. In further embodiments,both an audible alarm and a vibration alarm may be given at the sametime.

As shown in FIG. 5, embodiments of the external infusion device 10 willutilize a segmented screen LCD 28 that offers multiple-languagecapability in approximately 6 languages. However, alternativeembodiments may include larger or smaller language capabilities. Furtheralternative embodiments, may utilize an LCD that uses a dot matrix,active matrix, or the like. A scratch resistant window may be utilizedto provide improved durability, better viewing and less glare.

Several programming options will be available in the external infusiondevice 10, and will include at least two customized basal profiles, acarbohydrate (or bolus) estimator 14 and an alarm clock, as well asremote and on-device programming. Additionally, a physician/educatorwill be able to configure the external infusion device 10 through aCommunications Station (Communication-Station—shown in FIG. 15) toprovide or restrict access to certain programming options. Particularembodiments of the external infusion device 10 will also download storedinformation through the Communication-Station. Further description of aCommunication Station of this general type is be found in U.S. Pat. No.5,376,070 to Purvis et al., entitled DATA TRANSFER SYSTEM FOR ANINFUSION PUMP, which is herein incorporated by reference. Thisinformation can be used alone or combined with information from aGlucose Meter and/or a Glucose Sensor (not shown) to assist the userand/or the health care professional in making intelligent therapydecisions. Moreover, the information, programs and data may bedownloaded to a remote or local PC, laptop, Communication-Station, orthe like, for analysis and review by a MiniMed or a trained health careprofessional through the transmitter/receiver 26. The data may also bedownloaded through a Communication-Station 8 to a remotely locatedcomputer 6 such as a PC, laptop, or the like, over communication lines7, by modem or wireless connection, as shown in FIG. 15.

The external infusion device 10 will also have additional memorycapacity to allow configuring of the display during manufacturing todisplay information in several different foreign languages, and allowfor future upgrades and revisions without the requirement of a hardwarechange. For example, a PC program will enable manufacturing to selectthe language for the pump. Languages are contingent upon availablespace, but will include English, French, Spanish, Italian, Dutch,Swedish and German. In alternative embodiments, other languages will bedetermined based upon space availability.

RF Programmer

The remote RF programmer 12 (or remote commander) will enable the userto perform basic external infusion device 10 programming steps withoutaccessing the keyboard 24 on the external infusion device 10 or lookingat the LCD (Liquid Crystal Display) 28 screen. This will benefitvisually impaired users of the external infusion device 10, since theremote RF programmer 12 will give them ready access to the most commonlyused operations of the external infusion device 10, and will obviate theneed for visual feedback. Of particular importance to the sight impairedwill be the auditory feedback (and/or vibration feedback as discussedbelow) that the external infusion device 10 will provide. Theinstructions from the RF programmer 12 will be confirmed by a series ofaudible beeps (or if requested by programming, vibration) from theexternal infusion device 10. In alternative embodiments, the RFprogrammer 12 may include a receiver and provide an audio (or vibration)indication that the commands have been received and acknowledged by theexternal infusion device 10. In further embodiments, the keypad 102 onthe remote RF programmer 12 will have the letters defining thecapability of the key encoded in Braille, and the ridges that orient theuser to the keypad 102 will be quite pronounced to assist in guiding theuser to the proper function key. Other embodiments may utilize keys thathave different sizes or shapes to further enhance the ability for usersto identify the correct buttons to activate the various features andfunctions.

A remote RF programmer 12 will provide convenience and discretion forthe user of the external infusion device 10 by allowing concealment ofthe external infusion device 10 under clothes, in pouches, or the like.Preferably, the RF programmer 12 is an optional accessory item on theexternal infusion device 10, and the external infusion device 10 will befully functional without the use of the RF programmer 12. However, inalternative embodiments, the keypad 24 in the external infusion device10 may be omitted and all programming would be handled by a local orremote PC, laptop, Communication-Station, RF programmer or the like. Inpreferred embodiments, the RF programmer 12 will also provide the userwith the ability to perform the following functions: deliver a bolus,suspend/restart the external infusion device, and set and cancel atemporary basal rate. However, in alternative embodiments, the RFprogrammer may include still additional capabilities such as datatransfer (e.g., external infusion device history data or data from othermedical devices), updates to software and programming, or the like. Inpreferred embodiments, the data transfer capabilities between the RFprogrammer 12 and the transmitter/receiver 26 of the external infusiondevice 10 are two-way. In alternative embodiments, the data transferfrom the RF programmer 12 to the external infusion device 10 is one-way,such that the RF programmer 12 does not receive transmissions from theexternal infusion device 10. In further embodiments, the RF programmeracts as a relay, or shuttle, for data transmission between the externalinfusion device 10 and a PC, laptop, Communication-station, or the like.

In addition, as shown in FIG. 16, a relay or repeater 4 may be used withan external infusion device 10 and an RF programmer 12 to increase thedistance from which the RF programmer 12 can be used with the externalinfusion device 10. For example, the relay could be used to provideinformation to parents of children using the external infusion device 10and allow them to program the external infusion device 10 from adistance with the RF programmer 12. The information could be used whenchildren are in another room during sleep or doing activities in alocation remote from the parents. In further embodiments, the relay 4can include the capability to sound an alarm. In addition, the relay 4may be capable of providing external infusion device 10 information to aremotely located individual via a modem connected to the relay 4 fordisplay on a monitor, pager or the like. In a still further embodimentof the present invention, the external infusion device 10 is capable ofbeing programmed by multiple RF programmers 12, as shown in FIG. 17. Forinstance, each RF programmer 12 would learn (or be programmed with) theunique code (discussed below) of the external infusion device 10. Thiswould be useful for users that desired to have multiple RF programmers12, such as at home, office and/or school or needed a replacement for anRF programmer that was lost.

In preferred embodiments, the RF programmer 12 is similar in appearanceto the type of remote that is used to lock and unlock car doors. It willhave four (4) keys on a keypad 102 on a housing 104, which will be laidout in a square grid pattern, similar in appearance and layout to thekeypad 24 on the external infusion device 10, as shown in FIGS. 2 and 3.In alternative embodiments, fewer keys may be used to simplify the RFprogrammer 12 (see FIG. 15), reduce manufacturing costs and/or to reducethe number of program capabilities available (such as Suspend (S), bolus(B), or the like). Preferably, the RF programmer 12 should include aring 106 that fits on a key ring to lessen the likelihood that it mightbe lost. It should also have a “quick release” feature to allow the userto disconnect it from the key ring. Preferably, the RF programmer 12 isless than 1 cubic inch in volume; although larger or smaller volumes maybe used. Preferred embodiments utilize RF frequencies; however,alternative embodiments, may use optical, infrared (IR), ultrasonicfrequencies, magnetic effects, or the like, to communicate with theexternal infusion device 10.

Alternative embodiments of the RF programmer (controller or commander)12′, as shown in FIG. 4, may have more complex keypad arrangements 152,and may include a display device 150, such as an LCD, LED, plasmascreen, or the like, to assist in programming the external infusiondevice 10. Further alternatives may include a microphone (not shown) andrelated circuitry to allow voice activated control of the externalinfusion device. In further alternative embodiments, the RF programmer12′ may be formed in larger sizes, comparable to a TV controller or apocket calculator, and may include a display to facilitate morecomplicated or easier programming. Still further embodiments, mayinclude the ability to receive data and information from the externalinfusion device 10 and/or a glucose monitoring device, and the abilityto relay the information to another medical device, external infusiondevice 10, glucose monitor device, PC, laptop, Communication-Station, orthe like. Data transmission may be to other devices or include thecapability to receive data or instructions. An RF activation capabilitymay be included in addition to the programming capability.

Each RF programmer 12 will include the capability to “learn” the uniquecode of the external infusion device 10 for which it is intended to beused. In one embodiment, the user will perform the following steps tolearn the unique code: 1) remove the battery from the RF programmer 12;2) wait a few seconds and then replace the battery in the batterycompartment; 3) press and hold the ACT key 110 on the remote keypad 102(preferably, the remote will confirm that it has been activated with along audible beep); and then the remote is held within approximately 12″to 18″ (alternatively larger or smaller distances may be used) of theexternal infusion device 10 to receive the unique code from thetransmitter/receiver 26 of the external infusion device 10. The RFprogrammer 12 will confirm successful learning of the unique code withaudible beeps and/or vibration from the external infusion device 10and/or RF programmer 12. In alternative embodiments, the user maymanually enter or scan in the unique code identifying the RF programmer.In further alternative embodiments, the RF programmer 12 may alsotransmit a unique identification code that uniquely identifies the RFprogrammer 12 to the external infusion device 10 so that the externalinfusion device 10 will only accept commands from a particular RFprogrammer 12. In other embodiments, the unique code includes the serialnumber of the device to prevent confusion with other devices. Inparticular embodiments, the RF programmer 12 transmits commands to theinfusion device 10, but does not include a receiver to receive back datafrom the infusion device 10. In this embodiment, the infusion device 10includes the ability to store 3 unique codes to permit the infusiondevice 10 to be programmed by up to 3 different RF programmers 12. Inother embodiments, the infusion device 10 may include more or lessstorage locations to permit programming of the infusion device 10 with acorresponding more or less number of RF programmers 12.

In preferred embodiments, the external infusion device 10 includes areceiver to receive the commands from the RF programmer 12. Normally,the receiver is in a standby mode (e.g., not receiving) and becomesactive for short periods every 2.5 seconds (approximately) to see ifthere is any RF activity from the RF programmer 12. In alternativeembodiments, the receiver of the external infusion device 10 may be oncontinuously or may become active more often or less often, with theselection being dependent on power capacity, expected frequency of useof the RF programmer 12, or the like. Generally, the receiver of theexternal infusion device 10 requires that the RF programmer send anactivating message for a period lasting about 5 seconds for the RFprogrammer to be recognized by the receiver. In alternative embodiments,longer or shorter periods of time for sending the activating message maybe used.

Once the receiver recognizes that there is a valid RE programmer 12sending a message to the external infusion device 10 (i.e., with thisdevice 10's unique code), the receiver will remain in an active modeuntil a complete sequence of commands has been received, or until thereceiver times out due to a lack of RF communications from the RFprogrammer 12. Preferably, upon recognition of a valid RF programmer 12trying to communicate with the receiver, the external infusion device 10will activate its audio beeper (or its vibrator or the like) to let theuser know that the external infusion device 10 has been activated by theRF programmer 12. Typically, the receiver of the infusion device 10expects to receive a message with a valid preamble and message type, arecognized unique code, a valid function code (e.g., activate, bolus,suspend, or the like), an appropriate message count used by the receiverfor reduction of RF interference problems, and a valid CRC on thetransmitted message to ensure message integrity. Alternativeembodiments, may include different message contents or components.

In operation, as discussed above, the RF programmer 12 may be used toprogram several capabilities, such as an audio (or vibration) bolus, asuspension of external infusion device operation, a temporary basalrate, an extended bolus (such as square wave, ramp, triangular or thelike) or dual wave bolus. In addition, the user may program a profiledbolus that uniquely matches the needs of the individual user (forinstance it may contain square, ramp, pulse or curved portions that makeup the profile to be delivered over a period of time). It should benoted that the capabilities may also be directly programmed on theexternal infusion device 10 using the same sequence on the keypad of theexternal infusion device 10. The following are examples of how thevarious capabilities can be programmed using the keypad 102 on the RFprogrammer 12 (or similarly with the keypad 24 on the external infusiondevice 10).

EXAMPLE I RF Programmed Audio Bolus

To deliver an audio bolus with the RF programmer 12, the user will pressthe “B” or Up arrow key (▴) 108 in the upper right hand corner of the RFprogrammer 12 keypad 102. Each time the Up arrow key (▴) 108 is pushedthe amount of the audio bolus will increment in either 0.5 units or 1.0units (depending on what the user programmed as the incremental step onthe “audio” screen of the Set-up 1 menu—alternative embodiments may useother increments). In these examples, units are an increment of insulin.However, alternative embodiments, may define units to be any fluidvolume, such as micro-liters, ccs, or the like, with the volume beingdependent on the type of fluid to be infused. If the user exceeds thedesired setting he can wait for an error signal, such as a “raspberry”type sound, buzzing, vibration, or the like, and then press the Up arrowkey (▴) 108 on the RF programmer 12 to begin the process again.

When the desired audio bolus amount is programmed, the user presses the“activate” or ACT key 110 in the lower left corner of the keypad 102 onthe RF programmer 12. The external infusion device 10 will then confirmthe audio bolus amount with a series of audible beeps. In alternativeembodiments, vibration may be used instead of or in addition to audiblebeeps. To deliver the audio bolus, the user will then press the ACT key110 again to start delivery of the bolus. Alternatively, the externalinfusion device 10 may provide an audible indication by speech. Infurther alternative embodiments, the RF programmer 12′ will have adisplay 150 and will provide a visual confirmation with or without anaudio confirmation.

Counting the bolus increments will be facilitated by varying the audiotones for beeps that accompany the Up arrow key (▴) 108 presses. Fournotes belonging to a musical chord will be used in repeating sequence asthe Up arrow key (▴) 108 is repeatedly pressed to select a desired bolusamount. In alternative embodiments, more or fewer notes (and/orvibration) may be used. For example, if 0.5U (U-100) is the bolusincrement, the first key press of the Up arrow key (▴) 108 will set theexternal infusion device 10 and LCD 28 to 0.5 U, and it will beaccompanied by the first note in a chord. The second key press of the Uparrow key (▴) 108 will increment the external infusion device and theLCD 28 to 1.0 U, and it will be accompanied by the second note in thechord. The third key press of the Up arrow key (▴) 108 will incrementthe external infusion device 10 and LCD 28 to 1.5 U, and it will beaccompanied by the third note in the chord. The fourth key press of theUp arrow key (▴) 108 will increment the external infusion device 10 andthe LCD 28 to 2.0 U, and it will also be accompanied by the fourth notein the chord. On the fifth key press of the Up arrow key (▴) 108, thedisplayed bolus amount will be incremented again and the audio sequencewill repeat in the same manner as just described.

When the desired bolus amount is displayed and/or sounded, the usercontinues by pressing the ACT key 110. The external infusion device 10will play back the beep sequence generated during the bolus amountselection. The bolus delivery will commence after the user confirms thebolus amount selection by pressing the ACT key 110 once again. To cancelthis bolus before it starts, the user may either allow the externalinfusion device 10 to time out and return to the time display or pressthe Down arrow key (▾) 112. Either of these will be accompanied by a“raspberry” type beep (and/or vibration) indicating the bolus has beencleared. Preferably, a standard time-out delay of 15 seconds applies toall keypresses involved during the bolus amount selection, but othertime periods may be used.

Preferably, a BOLUS element, the word DELIVERY, and the updated amountdelivered will be displayed on the LCD 28 while delivery is in progress.The external infusion device 10 will beep once at the end of the dose.In alternative embodiments, audible indications may be provided, such asbeeps, chords, speech, or the like, and/or vibration.

EXAMPLE II RF Programmed Suspension of External Infusion DeviceOperation

To temporarily suspend the operation of the external infusion device 10,the user will press the “select” or SEL key 114 in the upper left handcorner of the keypad 102 of the remote RF programmer 12, and then pressthe ACT key 110. The external infusion device 10 will confirm that it isin suspend mode with three (3) audible beeps (although different numbersof beeps and/or vibration may be used). In preferred embodiments, whenthe external infusion device 10 is in suspend mode, the LCD 28 will show“-S-”, the word “STOPPED”, and the time that the external infusiondevice 10 was placed in the suspend mode. When in the suspend mode,there is no drug delivery (either basal rate, or meal boluses).Preferably, the external infusion device 10 will beep an alert tone(and/or vibrate) every half hour to indicate that delivery has stopped.In alternative embodiments, other time periods may be used, or the alerttone may be omitted.

To restart the external infusion device 10, the user will again pressthe SEL key 114 and then presses the ACT key 110. The external infusiondevice 10 will beep once (and/or vibrate) to confirm the restart andthen resume normal basal delivery and infusion device 10 operation.Alternatively, the external infusion device 10 may provide an audibleindication by speech. In further alternative embodiments, the RFprogrammer 12′ will have a display 150 and will provide a visualconfirmation of the status of the external infusion device 10, with orwithout an audio confirmation.

EXAMPLE III RF Programmed Temporary Basal Rate

A temporary basal rate, or basal override rate, is a rate that isdelivered in lieu of a programmed, user defined profile segment ratethat is generally delivered during this time period. The temporary basalrate is programmed with a rate and a duration.

To set a temporary basal rate, the user will press the “T” or Down arrowkey (▾) 112 in the lower right hand corner of the keypad 102 on the RFprogrammer 12. Each press of the Down arrow key (▾) 112 will incrementthe duration of the temporary basal rate by 30 minutes. Counting thetemporary basal rate duration increments will be facilitated by varyingthe audio tones for beeps that accompany the Down arrow key (▾) 112presses. Four notes belonging to a musical chord will be used inrepeating sequence as Down arrow key (▾) 112 is repeatedly pressed toselect a desired duration of the basal rate. In alternative embodiments,more or fewer notes (and/or vibration) may be used. The temporary basalduration may be programmed from 30 minutes to 24 hours in half-hourincrements. In alternative embodiments, other time periods may be used.In preferred embodiments, the tone of the beeps for a temporary basalrate may be distinctly different from a tone for incrementing a bolus.In alternative embodiments, different vibration may be used instead orin addition to the different audible beeps. If the user exceeds thedesired setting, they can wait for an error signal, such as a“raspberry”, buzzing, vibration, or the like, and then press the Downarrow (▾) 112 to begin the process again.

When the desired temporary basal rate duration has been set, the userwill press the ACT key 110. The external infusion device 10 will confirmthe duration of the temporary bolus rate with a series of audible beeps(and/or vibration). The user will then press the ACT key 110 again toconfirm and accept the duration of the temporary basal rate. If the ACTkey 110 is not pushed to confirm the amount, the external infusiondevice 10 will emit an audible error signal such as a “raspberry”,buzzing, vibration, or the like. Alternatively, the external infusiondevice 10 may provide an audible indication by speech. In furtheralternative embodiments, the RF programmer 12′ will have a display 150and will provide visual confirmation of the temporary basal rateduration, with or without an audio confirmation.

To set the amount of the temporary basal rate, the user will press theDown arrow key (▾) 112 again. Each press of the Down arrow key (▾) 112will increment the amount of the temporary basal by 0.1 units. Countingthe amount temporary basal rate increments will be facilitated byvarying the audio tones for beeps that accompany the Down arrow key (▾)112 presses. Four notes belonging to a musical chord will be used inrepeating sequence as Down arrow key (▾) 112 is repeatedly pressed toselect a desired amount of the temporary basal rate. In alternativeembodiments, more or fewer notes (and/or vibration) may be used. Inthese examples, units are an increment of insulin. However, alternativeembodiments may define units to be any fluid volume, such asmicro-liters, ccs, or the like with the volume being dependent on thetype of fluid to be infused. The rate may be set to a value from 0.0 Uto the maximum programmable value of the basal rate. In alternativeembodiments, different increments may be used. Preferably, the tone ofthese beeps (and/or vibration) will be distinctly different than thetone (and/or vibration) for setting the duration of the temporary basalrate. Once the desired amount has been set, the user will press the ACTkey 110. The external infusion device 10 will confirm the amount of thetemporary basal rate with a series of audible beeps (and/or vibration).The user will then press the ACT key 110 again to confirm and accept theamount of the temporary basal rate. If the ACT key 110 is not pushed toconfirm the amount, the external infusion device 10 will emit an audibleerror signal, such as “raspberry”, buzzing, vibration, or the like.Three short beeps (an/or vibration) every 30 minutes will confirm thatthe temporary basal rate is active. Alternatively, the external infusiondevice 10 may provide an audible indication by speech. In furtheralternative embodiments, the RF programmer 12′ will have a display 150and will provide visual confirmation of the temporary basal rate, withor without an audio confirmation.

To cancel a programmed temporary basal rate at any time during itsintended operation, and resume the normal programmed basal rate, theuser presses the Down arrow key (▾) 112 and then presses the SEL key 114on the keypad 102 of the RF programmer 12. If a temporary basal rate hadtime remaining, the user will hear a long beep (and/or vibrate) toconfirm that the temporary basal has been canceled. Otherwise, if notime was remaining, the user hears an error signal such as a“raspberry”, buzzing, vibration, or the like, indicating that there wasno time remaining on the temporary basal rate. Alternatively, theexternal infusion device 10 may provide an audible indication by speech.In further alternative embodiments, the RF programmer 12′ will have adisplay 150 and will provide visual confirmation of the temporary basalrate, with or without an audio confirmation.

EXAMPLE IV RF Programmed Extended Bolus

An extended bolus (such as a square wave bolus, ramp bolus, triangularbolus, profiled bolus or the like) is a bolus that is delivered over anextended period of time; rather, than all being delivered at once. Toprogram an extended bolus with the RF programmer 12, the user will needaccess to the display LCD 28 of the external infusion device or performthe programming in two separate steps. Alternatively, an RF programmer12′ having a built in display 150 may be used.

To set an extended bolus, the user will set the duration of the extendedbolus in the same manner that they set the duration for a TemporaryBasal Rate. This involves using the Down arrow key (▾) 112 in the lowerright corner of the keypad of the RF programmer 12, in the same manneras described above. The user will also select the type of extended bolussuch as a square wave bolus, ramp bolus, triangular bolus, profiledbolus, or the like, to be delivered by previous selection of the type ofextended bolus in the setup mode or by using an RF programmer inconjunction with a display. The remainder of the example demonstratessetting a square wave bolus.

When the ACT key 110 is pressed while a desired bolus amount isdisplayed, the bolus duration will be displayed on the LCD 28. Thedefault bolus duration can be 30, 60 or 90 minutes, depending on thelargest basal value of current setting and the desired bolus amount. Theduration may be scrolled by using the Up arrow key (▴) 108 and the Downarrow key (▾) 112 on the keypad 102 of the RF programmer 12. Pressingthe Up arrow key (▴) 108 will cause the duration to scroll in incrementsof 30 minutes up to 8 hours (the preferred maximum duration—althoughother durations or increments may be used), at which point it will wraparound to minimum duration. Pressing the Down arrow key (▾) 112 willcause the duration to wrap around to 8 hours, then scroll down inincrements of 30 minutes. In further embodiments, the use of the Downarrow (▾) 112 will always stop at zero to avoid a wrap-around or requireone or more additional depressions (possibly accompanied by a beepand/or vibration) to warn a user that they are now at the maximum value.Alternatively, the RTZ programmer 12′ may include different additionalkeys (such as 152 in FIG. 4) that can be used to implement the squarewave bolus, or a selectable menu on the RF programmer 12′.

Next, to set the amount of the square wave bolus, the user will pressthe Up arrow key (▴) 108 in the upper right hand corner of the keypad102 of the RF programmer 12. Each depression will enable incrementingthe amount of the square wave bolus in 0.1 unit increments; althoughother increments may be used. The external infusion device 10 will givea distinct auditory (and/or vibrating) confirmation of the selectedbolus amount. The square wave will not be implemented until the userpresses the ACT key 110 to accept the selected amount. Preferably, theexternal infusion device 10 provides confirmation by an audible beep(and/or vibration). Alternatively, the external infusion device 10 mayprovide an audible indication by speech. In further alternativeembodiments, the RF programmer 12′ will have a display 152 and willprovide visual confirmation of the square wave bolus, with or without anaudio confirmation.

To enhance flexibility, preferred embodiments of the external infusiondevice 10 will enable the user to deliver a normal bolus during aprogrammed Square Wave. Once the normal bolus has been delivered, thesquare wave will resume operation until completed.

EXAMPLE V RF Programmed Dual Wave Bolus

A dual wave bolus is a combination of a normal (or immediately given)bolus with a square wave bolus. To program a dual wave bolus with the RFprogrammer 12, the user will need access to the display LCD 28 of theexternal infusion device or perform the programming in two separatesteps. Alternatively, an RF programmer 12′ having a built in display 150may be used.

To set a dual wave bolus, the user will press the ACT key 110 on thebolus history screen. The word “NORMAL” will start to blank on the CD 28and/or provide an audible (and/or vibration) indication. The user canpress the Up arrow key (▴) 108 or Down arrow key (▾) 112 to choose thetype of bolus desired. By pressing the ACT key 110, while the LCD 28 ofthe external infusion device 10 blinks the word “DUAL” (and/or providesan audible indication), a dual bolus is chosen. The LCD 28 of theexternal infusion device 10 will show the word “NOW” and/or the dashesfor the normal bolus portion amount will blink on the LCD 28 (and/or anaudible and/or vibration indication is provided). The user can thenselect a bolus amount for the “normal” bolus portion using the Up arrowkey (▴) 108 or Down arrow key (▾) 112, and then press the ACT key 110.The LCD 28 of the external infusion device 10 will show the word“SQUARE” and/or the dashes for the bolus amount will now blink (and/oran audible and/or vibration indication is provided). The user can pressthe Up arrow key (▴) 108 or the Down arrow key (▾) 112 to choose thedesired square wave bolus portion amount. When the ACT key 110 ispressed, while a desired square wave bolus portion amount is displayedon the LCD 28, the square wave bolus portion duration will be thendisplayed (and/or an audible and/or vibration indication is provided).The user can then select the desired square wave bolus portion durationfrom 30 minutes to 8 hours (although other increments or duration's maybe used). After the ACT key 110 is pressed for the desired square wavebolus portion duration, the external infusion device 10 will startdelivering the normal bolus portion first. The square wave bolus portionwill then start right after the end of the normal bolus portion. Theword “BOLUS” and the amount of the bolus that has been delivered so farwill be displayed on the LCD 28 (and/or an audible and/or vibrationindication will be provided). When the dual bolus is finished, theexternal infusion device 10 will beep (and/or vibrate) and display theamount of the bolus delivered for 5 seconds, then return to the normaltime display. Alternatively, the external infusion device 10 may providean audible indication by speech. In further alternative embodiments, theRF programmer 12′ will have a display 150 and will provide visualconfirmation of the square wave bolus, with or without an audioconfirmation.

Other programming, commands, or data transfer may be accomplished by theRF programmer 12 (or remote commander), and the RF programmer 12 (orremote commander) should not be limited to the above-described ExamplesI–V. For instance, the RF programmer 12′, since it includes a display150 may use the same programming protocol and key sequences as thoseused to program the external infusion device 10 using the keypad 24 andLCD 28 on the external infusion device 10. Alternatively, the RFprogrammer 12′ may use more sophisticated programming techniques, suchas single key programming, if the display 150 includes the capability touse touch screen techniques, or may use additional keys in the keypad152 that are specifically identified with particular programmingfeatures on the external infusion device 10.

Bolus Estimator

The Bolus estimator 14 (or carbohydrate estimator that estimates a bolusbased on carbohydrate consumption (CHO)) assists the user withcarbohydrate counting and in determining precise dosing adjustments toaccount for meals. Carbohydrates are the primary, but not the only,factor affecting blood glucose levels. Generally, it is sufficient toaccount just for the carbohydrates. It also encourages the user to entercurrent blood glucose values before using this feature, which will alsobe viewed quite favorably by the health care professional, since itincreases compliance with the medical regimen and improves control. Inalternative embodiments, the bolus estimator 14 in the external infusiondevice 10 can be connected or coupled to a glucose monitor by way of theRF programmer 12 (or other data transfer) to provide direct input to thebolus estimator 14.

In preferred embodiments, as shown in FIGS. 1, 6, 7 and 8(b), the bolusestimator 14 is used to assist the external infusion device 10 user withthe estimations that are done to determine the proper bolus amount thatis needed to cover the anticipated carbohydrate intake at meals. Thebolus estimator 14 does this by suggesting a bolus based on apre-programmed carbohydrate ratio that is stored in the memory 22 of theexternal infusion device 10. The bolus estimator 14 will also take intoaccount the user's insulin sensitivity and the differential between theuser's pre-programmed target blood glucose (BG) level and the user'scurrent BG level at the time the carbohydrate estimator 14 is activated.The recommendation, or result of the bolus estimator 14, is sometimesreferred to as a “correction bolus”.

The bolus estimator 14 is generally activated by the user, or preferablythe health care professional, in the Set-up II menu of the externalinfusion device 10 (see FIGS. 6 and 8( b)), before it is operational,and preferably after the user has demonstrated a sufficientunderstanding of estimating carbohydrate intake. In preferredembodiments, the bolus estimator 14 is activated and programmed by usingthe keypad 24 on the external infusion device 10. However, inalternative embodiments, the bolus estimator 14 may be programmed andactivated with an RF programmer 12 or 12′. In further alternativeembodiments, the current glucose readings for the user my be provided byreceipt of the glucose level measurement from a glucose monitor or viathe RF programmer 12 to facilitate a correction for changing bloodglucose (BG) levels. Further description of correcting infusion ratesbased on blood glucose readings may be found in U.S. Pat. No. 5,569,186to Lord et al., entitled “CLOSED LOOP INFUSION PUMP SYSTEM WITHREMOVABLE GLUCOSE SENSOR,” and U.S. Pat. No. 5,665,065 to Colman et al.,entitled “MEDICATION INFUSION DEVICE WITH BLOOD GLUCOSE DATA INPUT”,which are herein incorporated by reference. In alternative embodiments,the user may be able to use other combinations of the values to suggestdifferent bolus types and amounts. In alternative embodiments, thecarbohydrate estimator 14 can be used in a closed-loop system to augmentthe readings or check the closed-loop system's capability based oncarbohydrate estimated meals. In still further embodiments, the bolusestimator 14 may be used to calculate correction boluses based on otherparameters, with the type of bolus corrections being determined by thefluid being infused, body characteristics, or the like. Preferably, thebolus estimator 14 uses stored values or parameters related to theindividual with current values, parameters or measurements and analgorithm to provide a recommended bolus that can be accepted, modifiedor rejected by the user. For instance in pregnancy, tocolysis may beinfused and the measurement of the contraction rate may be used tosuggest additional boluses of tocolysis medication. In HIV cases, abolus amount of medication being infused may be adjusted based on arelationship to the current viral loads in the patient. In stroke orcardiac cases, the coagulation rate may be used to determine the bolusamount of heparin to be administered. Other calculations may be made andshould not be limited to the above-described examples.

After the bolus estimator 14 has been enabled, the user will be promptedto store the following three (3) values in the memory 22 of the externalinfusion device 10. In alternative embodiments, more or fewer values maybe needed or used. These values are used by the bolus estimator 14 andthe processor 18 of the external infusion device 10 to perform thenecessary calculations in suggesting a bolus amount. In preferredembodiments, access to programming and changing these values may berestricted to the health care professional. In alternative embodiments,these values can be restricted to entry through an RF programmer 12 or aconnection of the external infusion device 10 with a programming device,such as a PC, laptop or the like. The inputted values needed to bestored for the bolus estimator 14 are:

Target Blood Glucose (Target), which is the target blood glucose (BG)that the user would like to achieve and maintain. Generally, theprogrammable blood glucose (BG) values for this range are between 60 to200 in five unit increments. Preferably, the carbohydrate calculator hasthe capability to accept values that range between 20 to 600 in 1 unitincrements to cover a large number of possible scenarios. However, inalternative embodiments, different ranges and increments may be used.

Insulin Sensitivity (Set Sens), which is a value that reflects how farthe user's blood glucose drops in milligrams per deciliter (mg/dl) whenone unit of insulin is taken. Preferably, the programmable values forthis range are between 5 to 180 in one unit increments. However, inalternative embodiments, different ranges and increments may be used. Inpreferred embodiments, insulin sensitivity is programmable for up tofour different time periods, the use of which will require four separateprofiles to be stored in the memory 22. Setting the Insulin Sensitivityprofiles is similar to setting the basal profiles. In alternativeembodiments, more or fewer time periods (and corresponding profiles) maybe used.

Carbohydrate Ratio (Set Carbs), which is a value that reflects theamount of carbohydrates that are covered by one unit of insulin.Generally, the values are in the range of 1 to 300 in increments of 1unit (or, alternatively, in ranges of 0.1 to 5.0 in increments of 0.1for carbohydrate exchanges). Preferably, the programmable values forthis range are between 5 to 30 in one unit increments. However, inalternative embodiments, different ranges and increments may be used.

As a safety precaution, the user or healthcare professional may also seta Lockout Period, which takes into account the pharmacokinetic effect ofinsulin when suggesting a bolus. The purpose is to prevent a successiveuse of a correction bolus when the pharmacokinetic effects of theprevious bolus have not yet been accounted for. The programmable valuesfor this range are between 30 minutes to 240 minutes, programmable in 15or 30 minute increments. However, in alternative embodiments, differentranges and increments may be used. In further alternative embodiments,the lock out period may be automatically calculated based on bolusesrecently delivered and/or canceled based on new blood glucose (BG)readings. In other embodiments, the carbohydrate calculator 14 mayinclude a programmable reminder to check the post-prandial blood glucosevalue to determine if additional boluses and or corrections should bemade at a later time after the meal. The programmable reminder valuesare between 30 minutes to 240 minutes, programmable in 15 or 30 minuteincrements. However, in alternative embodiments, different values andincrements may be used.

After the above values are set in the memory 22 of the external infusiondevice 10, the bolus estimator 14 will suggest a bolus based on theentry of the estimated carbohydrate intake and current and target bloodglucose (BG) levels. The calculation will only be performed if the threevalues are programmed and stored in the memory 22. Preferred embodimentsuse the following equation:

${Bolus} = {\frac{\left( {{{Current}\;{BG}} - {{Target}\;{BG}}} \right)}{InsulinSensitivity} + \frac{CarbohydratesToBeConsumed}{CarbohydrateRatio}}$

If the user wishes the external infusion device 10 to suggest a bolusfor the estimated carbohydrate intake only, then the only value theyneed to program is for the Carbohydrate Ratio, and the BG portion of theequation will be ignored. In alternative embodiments, variations ordifferent equations may be used.

In operation, once the bolus estimator 14 has been enabled and the abovelisted values have been programmed into the memory 22 of the externalinfusion device 10 the bolus estimator 14 can be used to suggest acorrection or meal bolus. The user may then accept or change the bolusamount suggested by the bolus estimator 14. In one embodiment, processor18 stores in memory 22 a record of whether the suggested bolus amountfrom the bolus estimator 14 was accepted or changed by the user, andrecords the suggested and changed bolus amounts. The stored data can beused for later analysis by downloading the data to a computer by RF orIR transmissions, for example by IR transmissions from the externalinfusion device 10 through the communication station 8 to the computer6, as shown in FIG. 15, or the like. The following examples illustratehypothetical carbohydrate calculation scenarios. The examples show useof the bolus estimator 14 by the keypad 24 on the external infusiondevice 10. However, it should be understood that the bolus estimator 14could be activated and programmed by the RF programmer 12 or the like.Alternatively, the keypad 24 (or RF programmer 12) may include anadditional key.

Preferred embodiments use a normal bolus. In alternative embodiments,the user may be given the choice of a normal, dual, square wave bolus,extended bolus, profiled bolus, or the like, by enabling thesecapabilities on the variable bolus menu in the Setup 11 menu (see FIGS.6 and 8) on the external infusion device 10. If the variable boluscapability is not enabled, then every bolus would be a normal bolus. Asdiscussed, preferred embodiments of the present invention use normal onetime boluses. However, alternative embodiments may utilize differentbolus types to spread out the correction or meal bolus determined by thecarbohydrate estimator 14.

The same set of pre-programmed values as described above and shown belowin Table 1 will be used for each of the following examples VI–IX:

TABLE 1 Pre-programmed Values for the Examples Pre-programmed ValuesTarget BG: 100 Insulin Sensitivity: 30 Carbohydrate Ratio: 15 LockoutPeriod: 60

EXAMPLE VI Bolus Estimator—Square Wave

The user presses the SEL key 114 and then the ACT key 110 on theexternal infusion device 10 to choose a “Normal” bolus, and uses the ACTkey 110 to select the carbohydrate estimator 14. To operate the bolusestimator 14, and assuming that the user measures his/her blood sugarlevel to be 160 mg/dl, and assuming the user estimates that a meal of 75grams of carbohydrates is to be consumed, the following “dialog” occursbetween the user and the external infusion device 10:

-   -   External infusion device 10 Prompt: “Enter BG” (preferably,        there will be three dashes in the upper right corner of the        display—although other displays or indications may be used).    -   User: Enters the value “160” by scrolling the Up arrow key 10        and pressing the ACT key 110. 160 is displayed and then entered.    -   External infusion device 10 Prompt: “#gm CHO” meaning the number        of grams of carbohydrate to be consumed (there will be three        dashes in the upper right corner of the display—although other        displays or indications may be used).    -   User: Enters the value “75” by scrolling the Up arrow key (▴)        108 and pressing the ACT key 110. 75 is displayed and then        entered.    -   External infusion device 10 Prompt: Suggests a “7.0” unit bolus        (2 units of correction and 5 units to account for the        carbohydrates to be consumed).    -   User: Can accept the suggested bolus by pushing the ACT key 110        or use the Up arrow key (▴) 108 or the Down arrow key (▾) 112 to        select a different bolus amount, and then presses the ACT key        0.110 to start the bolus.

EXAMPLE VII Bolus Estimator—Dual Wave

The user presses the SEL key 114 and chooses a “Dual” wave bolus, andthen the ACT key 110. To operate the bolus estimator 14, and assumingthat the user measures his/her blood sugar level to be 160 mg/dl, andassuming the user estimates that a meal of 75 grams of carbohydrates isto be consumed, the following “dialog” occurs between the user and theexternal infusion device 10. The following “dialog” will then take placebetween the user and the external infusion device 10:

-   -   External infusion device 10 Prompt: “Enter BG” (there will be        three clashes in the upper right corner of the display although        other displays or indications may be used).    -   User: Enters the value “160” by scrolling the Up arrow key (▴)        108 and pressing the ACT key 110. 160 is displayed and then        entered.    -   External infusion device 10 Prompt: “#gm Carbs” which means the        number of grams of carbohydrate to be consumed (there will be        three dashes in the upper right corner of the display—although        other displays or indications may be used).    -   User: Enters the value “75” by scrolling the Up arrow key (▴)        108 and presses the ACT key 110. 75 is displayed and then        entered.    -   External infusion device 10 Prompt: Suggests a “7.0” unit bolus.    -   User: Can accept the suggested bolus by pressing the ACT key 110        or use the Up arrow key (▴) 108 or the Down arrow key (▾) 112 to        select a different bolus amount.    -   External infusion device 10 Prompt: “Now” with the accepted        value of “7.0” units blinking. Typically the user will scroll        down using the Down arrow key (▾) 112 to select only part of the        bolus now. Lets say the user selects “2.0” and presses the ACT        Key 110.    -   External infusion device 10 Prompt: “Square” will appear on the        screen with the remainder of the bolus (i.e., “5.0”) blinking.        The user can again select this amount or scroll to a different        amount. The duration will be set by activating the SEL key 114        and incrementing the time.

EXAMPLE VIII Bolus Estimator—Square Wave—Lower BG

The user presses the SEL key 114 and then the ACT key 110 on theexternal infusion device 10 to choose a “Normal” bolus, and uses the ACTkey 110 to select the bolus estimator 14. To operate the bolus estimator14, and assuming that the user measures his/her blood sugar level to be70 mg/dl, and assuming the user estimates that a meal of 75 grams ofcarbohydrates is to be consumed, the following “dialog” occurs betweenthe user and the external infusion device 10:

-   -   External infusion device 10 Prompt: “Enter BG” (there will be        three dashes in the upper right corner of the display—although        other displays or indications may be used).    -   User: Enters the value “70” by scrolling the Up arrow key (▴)        108 and pressing the ACT key 110. 70 is displayed and then        entered.    -   External infusion device 10 Prompt: “#gm Carbs” which means the        number of grams of carbohydrate to be consumed (there will be        three dashes in the upper right corner of the display—although        other displays or indications may be used).    -   User: Enters the value “75” by scrolling the Up arrow key (▴)        108 and presses the ACT key 110. 75 is displayed and then        entered.    -   External infusion device 10 Prompt: Suggests a “4.0” unit bolus        (−1 unit correction and 5 units to account for the carbohydrates        to be consumed).    -   User: Can accept the suggested bolus by pressing the ACT key 110        or use the Up arrow key (▴) 108 or the Down arrow key (▾) 112 to        select a different bolus amount.

Preferred embodiments of the bolus estimator 14 utilize general rules tominimize the potential for inaccurate results from the bolus estimator14 or administering a bolus at an inappropriate time. For instance, if acorrection bolus has been previously given such that the BG Now >BGTarget, then the Lockout period is activated and the bolus estimator 14will not calculate a correction bolus. In alternative embodiments, thebolus estimator 14 may determine a bolus based on carbohydrates to beconsumed and omit the portion of the calculation that utilizes the bloodglucose level to determine the correction portion of the bolus. Thus,the external infusion device 10 will not prompt the user with “Enter BG”during the Lockout period, and will effectively operate only as acarbohydrate estimator. Once the Lockout period has expired, theexternal infusion device 10 will prompt the user for a current BG value,and then suggest a correction bolus if the user enters a current BGvalue. Also, if the bolus estimator 14 estimates a bolus to be anegative value (BG is below target and carbohydrate intake amount isminimal) then the external infusion device 10 will display “No Bolus!”as a warning. Also, if the user enters a current blood glucose (BG)level that is lower than a certain value, such as 50 (although othervalues may be used), the external infusion device will display “Low BG”.

EXAMPLE IX Bolus Estimator—Insulin Duration Factor

A further embodiment of the bolus estimator 14 may include the abilityto account for the effects of recently taken insulin that is still, atleast partially, still active in the body of the user. The concern wouldbe that the remaining insulin could have the effect of lowering theblood glucose level too quickly, or too far, if the remaining insulinwas not accounted for. Thus, this embodiment utilizes an InsulinDuration Factor to account for the effects of the insulin stillremaining in the body.

The Insulin Duration Factor would also be a programmable parameter thatis in the Setup II section of the pump along with the other parameters,as described above. The user would program the approximate duration timethat insulin is active in their system. For instance, users of fastacting insulin analogs would program 1 to 4 hours in 15 or 30 minuteintervals, and users of Regular insulin would program 2 to 8 hours in 15or 30 minute intervals. However, in alternative embodiments, differentvalues and increments may be used. Preferably, the insulin durationfactor should be selected and adjusted by the health care professionalor the user upon recommendation and/or consultation with the health careprofessional. Preferred embodiments use the following equation (note ifa negative value is returned (i.e., the insulin from a previous bolus isused up) the equation will return a value of 0 for no insulin remainingto avoid over correcting):

${{InsulinRe}\mspace{11mu}{maining}} = {{\frac{\left( {{InsulinDurationFactor}\; - {TimeSinceLastBolus}} \right)}{InsulinDurationFactor}{If}} \geq 0}$OtherwiseInsulin Remaining=0

In this example, it is assumed that the user programs a 3 unitcorrection bolus at 11:00 am to correct for a 190 BG value. The userthen decides to use the bolus estimator 14 at 12 Noon to estimate abolus for meal containing 75 grams of carbohydrate. The Insulin DurationFactor is set to 3 hours. The user presses the SEL key 14 and then theACT key 110 on the external infusion device 10 to choose a “Normal”bolus, and uses the ACT key 110 to select the bolus estimator 14. Tooperate the bolus estimator 14, and assuming that the user measureshis/her blood sugar level to be 160 mg/di, and assuming the userestimates that a meal of 75 grams of carbohydrates is to be consumed,the following “dialog” occurs between the user and the external infusiondevice 10:

-   -   External infusion device 10 Prompt: “Enter BG” (preferably,        there will be three dashes in the upper right corner of the        display—although other displays or indications may be used).    -   User: Enters the value “160” by scrolling the Up arrow key 10        and pressing the ACT key 110. 160 is displayed and then entered.    -   External infusion device 10 Prompt: “#gm CHO” meaning the number        of grams of carbohydrate to be consumed (there will be three        dashes in the upper right corner of the display—although other        displays or indications may be used).    -   User: Enters the value “75” by scrolling the Up arrow key (▴)        108 and pressing the ACT key 110. 75 is displayed and then        entered.    -   Insulin Remaining: 3.0 (Insulin Taken)×⅔ (Insulin Duration        Remaining)=(2.0) units    -   External infusion device 10 Prompt: Suggests a “5.0” unit bolus        (2 units of correction and 5 units to account for the        carbohydrates to be consumed and a subtraction to account for        the remaining insulin in the user).    -   User: Can accept the suggested bolus by pushing the ACT key 110        or use the Up arrow key (▴) 108 or the Down arrow key (▾) 112 to        select a different bolus amount, and then presses the ACT key        110 to start the bolus.

Since the external infusion device 10 stores the time of each bolusdelivery, the above simple algorithm can be designed to take intoaccount the amount of insulin that might still be remaining in theuser's body from a previous bolus. The longer the programmed time forthe “Insulin Duration Factor” then the more conservative the estimatebecomes. In further embodiments, the external infusion device 10 couldadjust for several boluses that were delivered within the insulinduration window. Although it is difficult to predict how long insulinwill actually remain active in the body, the above described algorithmdoes at least consider the effects on the amount of insulin actuallyneeded. This provides an additional level of conservative estimation inthe external infusion device 10 by accounting for insulin deliveredwithin a programmable window. Without such an algorithm, in the exampleabove the pump would have suggested a “7.0” unit bolus because theremaining insulin would not have been accounted for in the suggestedbolus.

The bolus estimator 14 has the advantage of prompting the user to enterhis/her blood glucose (BG) value, and thus serves as a useful reminderto check BG levels regularly. This makes testing more advantageous thenever, since the results directly assist the user in maintaining controlof his/her condition. Also, the bolus estimator 14 enables the externalinfusion device 10 to capture information on carbohydrate intake whichis valuable for helping the user to refine carbohydrate counting skills.This data may also be downloaded to a PC, laptop, Communication-Station,RF programmer, or the like.

In further embodiments, an external infusion device 10 and user canutilize the bolus estimator 14 information to “learn” insulinsensitivity values, carbohydrate counting, the effects of high fat mealsand other variables that can lead to better control, and use this toadjust the results of the bolus estimator 14. In alternativeembodiments, the user can omit entering specific carbohydrate amountseach time calculations are made by the user. For instance, the externalinfusion device 10 may store the carbohydrate amounts for several mealsthat are regularly eaten by the user in the memory 22, and then allowthe user to recall the stored meals. In other alternative embodiments, alist of general foods may be provided with a carbohydrate equivalent. Instill further embodiments, the external infusion device 10 may utilize amore complicated keypad and/or RF programmer 12, and a code is assignedfor each food. Then the code for each food to be consumed is enteredinto the external infusion device 10.

Vibration Alarm

Further embodiments of the present invention include a vibration alarm16 that provides a noticeable vibration in addition to or in lieu of anaudible alarm. The resulting tactile sensation of the vibration make thealarms more noticeable during sleep, when not thinking clearly due tovarious conditions, or the like, to improve the likelihood that the userwill respond to an alarm. Thus, a vibration alarm 16 can improve safetyand control. In addition, the vibration alarm 16 may be less publiclynoticeable, and thus more useable in quiet settings, such as libraries,lectures, shows, or the like, or in loud settings where the alarm mightgo unnoticed, such as parties, concerts, or the like. In furtherembodiments, the RF programmer 12 may include a vibration alarm (notshown) that can deliver a vibration alarm to the user in addition to, orinstead of, the vibration alarm 16 from the external infusion device 10.Alternatively, the RF programmer 12 may provide a vibration alarm andthe external infusion device 10 may provide an audible alarm or viceversa.

The vibration alarm 16 also provides an additional capability usedduring priming or operation of the external infusion device 10. It hasbeen found that activating the vibration alarm 16, before or duringpriming, will assist in removing air bubbles in the reservoir or tubing.This procedure minimizes the amount of medication that must be expelledto clear the air bubbles, by allowing bubbles to move towards the outletand the tubing based on the agitation of the reservoir. Use of thevibration alarm 16 during priming can result in substantial savings whenusing expensive or concentrated medications with the external infusiondevice 10. This also simplifies and somewhat automates the priming ofthe external infusion device 10. In addition, the vibration alarm 16 maybe used to agitate the medication (such as suspensions of a drug) duringadministration so as to minimize sedimentation or separation of themedication, or, if power requirements are an issue, between infusionincrements of the fluid by the external infusion device 10, if suchagitation is desired.

Other Capabilities

Particular embodiments will include a “Low Reservoir Alert”. The alertwill sound when the plunger of the external infusion device 10 reachesthe point where approximately 0.200 ml of fluid remains in thereservoir. However, in alternative embodiments, larger or smalleractivation thresholds may be used. An icon indicating “Low Volume” willappear on the main LCD 28 screen until the condition is corrected. Ifcorrection of the low volume has not happened at an approximate level of0.100 ml, the external infusion device 10 will beep again. However, inalternative embodiments, larger or smaller activation thresholds may beused. Preferably, the external infusion device 10 will keep track of thereservoir volume in the software and request the user to update thereservoir volume manually whenever the prime function is activated.

Other embodiments may utilize a “Take a Break Bolus”. This isparticularly well adapted for short acting medications or fluids. Thepurpose of this capability is to deliver an extra bolus beforedisconnecting from the external infusion device 10, to make certain thatthe clinically needed amount of medication or fluid is delivered beforeinterrupting the administration. This will help the user remain abovethe minimum therapeutic level during an interruption of medication orfluid delivery. Preferably, four durations of an interruption of themedication or fluid infusion will be possible: 30 minutes; 1 hour; 1hour and 30 minutes; and 2 hours. However, additional, or longer orshorter internals may be used. Generally, this capability is activatedin the Setup II menu by the health care specialist, who will program thedose for each of the 4 possible times of delivery interruptions. Thedose is set based on the medication or fluid and the condition of theuser. If the health care specialist programs only certain durations (forexample 30 minutes and 1 hour only), the user will only be able to takea break for those durations. In preferred embodiments, in the “Take aBreak Bolus” screen, the user will program the duration of the plannedinterruption. The external infusion device 10 will then beep after thedelivery of the previously set dose. The user will then disconnect fromthe external infusion device 10 and will be reminded by the externalinfusion device 10 to reconnect when the time is up. Preferably, thereminder alarm will continue to sound (or vibrate) until the userreactivates the external infusion device 10.

Particular embodiments include a “Lockout function”. Preferredembodiments will have multiple lockout levels, with the selection bedependent on the anticipated usage, the external infusion device model,the sophistication of the user, or the like. For instance, the followinglockout levels may be used (a lockout levels means that some of thefeatures of the external infusion device will not be accessible to thepatient (or user), but will be accessible to the Health CareProfessional or the parent of a child using the external infusion device10):

-   -   “None” (0) will let the user program and access all features of        the external infusion device 10;    -   “Setup” (1) will lock the user out of changing both Setup I and        Setup II parameters. The user will only have access to activated        features of the external infusion device 10, but can not change        the pre-set parameters. The user will be able to review the        settings, and only change the lockout level with an authorized        key sequence. The only Setup feature that will still be        available is Selftest.    -   “All except Suspend” (2) will only allow the user to suspend the        external infusion device and to perform a Selftest. All other        features will be locked out. The user will be able to review the        settings, and only change the lockout level with an authorized        key sequence.

The “Lockout function” will be in Setup II. A special key sequence (orcode) will be required to change the lockout level. This will minimizethe possibility of an unauthorized change of the lockout levels. Inpreferred embodiments, an icon (lock) will be displayed on the LCD 28when the external infusion device 10 is in Lockout mode 1 or in Lockoutmode 2.

Preferred embodiments of the external infusion device 10 will include aconfigurable menu that is accessible by password through the use of aPC, laptop, RF programmer or the like. This ability allows thephysician, or sophisticated user, to select only the external infusiondevice 10 capabilities that are required for an individual user. A “lockout” capability will enable the physician to exclude certain optionsfrom the ser. This may be useful with new users or children using theexternal infusion device 10.

Further embodiments may include a “Suspend/Storage Mode”. In addition tothe regular Suspend Mode (discussed above), the external infusion device10 can be put in a “Storage Mode” in which no recurring alert (beepingand/or vibrating) will remind the user of the external infusion device10 being in the “Storage Mode”. Thus, for example, in “Suspend Mode”,the external infusion device 10 will display the time of day, STOPPEDand -S- on the LCD 28. In addition, the external infusion device 10 willbeep (and/or vibrate) 6 times every 30 minutes as a reminder. In suspend“Storage Mode”, the external infusion device 10 LCD 28 will display the-S- only and will not repeatedly beep (and/or vibrate).

In preferred embodiments, software options will appear as choices forthe user if they are first selected from the Main Menu, the Setup I andSetup II screen, as shown in FIGS. 6–12. The physician will also be ableto control what range of choices are available for the user, either inthe office or remotely through a PC connected to aCommunication-Station. In preferred embodiments, the external infusiondevice 10 will have the ability to transmit all the stored memorycontent to a Computer 6 or external FAX/Modem connected to aCommunication-Station 8, as shown in FIG. 15. Further description of aCommunication Station of this general type is be found in U.S. Pat. No.5,376,070 to Purvis et al., entitled DATA TRANSFER SYSTEM FOR ANINFUSION PUMP, which is herein incorporated by reference.

Preferred embodiments, use scrollable menus to set various capabilities.In alternative embodiments, different menu structures or ways of movingthrough the menus may be used. In preferred embodiments, the userpresses the SEL key 114 to scroll the external infusion device 10through a series of informative displays or Select States (e.g., mainmenu, setup I and setup II-see FIGS. 6–12). The displays differdepending upon the current status (state of software execution) of theexternal infusion device 10.

Preferably, the programming capabilities that are accessed infrequentlyare kept in the Setup menus. The external infusion device 10 has twolayers of setup menus, Setup I and Setup II. Setup I containscapabilities that are used more often than those in Setup II. Both SetupI and Setup II menus will be accessible through the main menu bypressing the SEL key 114 at the links between the Setup I and Setup II(see FIGS. 6–12). The Setup I menu (see FIGS. 10 and 12) will be enteredby pressing the ACT key 110, while the Setup I screen is beingdisplayed. While in the Setup I menu, the screens that are displayed areTime Adjustment, Automatic Off Duration, Beep Volume, User Self Test,Setup II and Setup Exit. The Setup II menu (see FIGS. 9 and 11) can beentered by pressing the ACT key 110 while the Setup II screen is beingdisplayed. While in the Setup II menu, the screens that are displayedare Audio Enhanced Bolus Mode On/Off & Increment, Variable Boluses ModeOn/Off, Bolus Estimator (carbohydrate calculator), Maximum Bolus,Maximum Basal rate, Time Mode ( 12/24 hour display), InsulinConcentration, Alarm Review, Alarm Mode, Child-lock (lock-out), Set RFDevice, Personal Delivery Patterns, Setup I and Setup Exit.

Generally, none of the values can be changed directly from the SelectStates. To alter a value on an informative display, the user must firstpress the ACT key 110. This is referred to as entering a Set State. Theword “SET” will appear on the display (and/or an audible and/orvibration indication is provided), and the value that can be changedwill be blinking. Pressing the Up arrow key (▴) 108 or the Down arrowkey (▾) 112 will change the blinking value. After scrolling to thedesired value, the ACT key 110 must be pressed again. This will activatethe new value and return the external infusion device 10 to the normaloperating (time) display. If more than one value can be changed on asingle display, pressing the ACT key 110 will cause the other value tobe selected and the Up arrow key (▴) 108 and the Down arrow key (▾) 112will affect this next value. Two general exceptions to the preferredrule governing the parameter selection described above are the normaloperating (time) display and the Total History state. Both are SelectStates. When the normal operating (time) display is in effect, pressingthe ACT key 110 will show the user the amount of battery power left, or,alternatively, or in addition to, the amount of medication remaining inthe reservoir (thus time cannot be changed from it, since time settingis handled in the SetUp I menu). The Total History state is forinformation only. Historical total values may be viewed directly fromthe select state with the arrow keys.

In preferred embodiments, if the external infusion device 10 is leftidle while in a Set State, the software will return to the time displaystate after approximately 15 seconds, no changed values will beactivated. If the external infusion device 10 is left idle in a SelectState, it will return to the time display state in approximately 7seconds. In alternative embodiments, longer or shorter time periods forthe various states may be used.

The external infusion device 10 will preferably include the followingSelect States in the main menu (see FIGS. 9 and 11): time display, bolushistory, suspend, basal rate, temporary basal rate, total history, primebolus, Setup I menu and Setup II menu. The Setup I menu (see FIGS. 10and 12) will feature the additional select states: time and dateadjustment, automatic off duration, beep volume, user self test, SetupII, and Setup exit. The Setup II menu (see FIGS. 6 and 8) will featurethe following options: audio enhanced bolus mode enable/disable &increment, variable bolus mode enable/disable, maximum bolus, maximumbasal rate, bolus estimator setting, personal delivery patternselection, alarm clock setting, insulin concentration, alarm review,lock-out, RF programmer set up, Setup I, and Setup exit. After acapability is activated in any Se State in the normal operating menu,the normal operating display (time display) will be displayed. Inalternative embodiments, other values may be displayed.

Preferably, after a capability is activated in one of the Setup menus,the next Setup Select State will be displayed. Once in one of the SetupMenus, the user may use the SEI, key 114 to view all of the Setup SelectStates until the keyboard is allowed to time out (in approximately 15seconds) or the user presses the ACT key 110 on the Exit Setup state.

Preferably, the SEL key 114 is used to select an option. For safety,using this key will never change any value. If there is more than oneoption in a single programming sequence (Set State), such as hours,minutes, and (late on the time setting display, the options are selectedwith the ACT key 110. The ACT key 110 is used to allow changing ofvalues by entering set states, and to activate changed values. The Uparrow key (▴) 108 and the Down arrow key (▾) 112 are available as validkeys when numbers or dashes are blinking. However, in preferredembodiments, there are two exceptions: while normal operating (time)screen is displayed, 1) pressing the Up arrow key (▴) 108 invokes theaudio enhanced bolus function if enabled in setup II and 2) pressing theDown arrow key (▾) 112 turns on the LCD backlighting. The backlight willremain on for about fifteen seconds after the last key press. Any keypress before the expiration of fifteen seconds will restart the fifteensecond time-out.

The external infusion device 10 can be programmed to deliver up toforty-eight basal rates daily. The user does not need to program allforty-eight rates. The multiple basal rates are called profile segments.Profile segments are preferably programmed with a start time and a basalrate. A profile segment rate will become active at the profile segmentstart time. This allows for several different delivery schedules tooccur without requiring the user to reprogram the external infusiondevice 10. The first profile segment always begins at midnight. Theother profile segments always start on even hour or half-hourboundaries. The delivery pattern will repeat daily. In alternativeembodiments, the external infusion device 10 may contain more, or less,than forty eight profiles, with amount being dependent on memory, timeincrement for each profile, and the like.

A Setup option will allow the user access to three “personal patterns”in order to accommodate individual lifestyle requirements. The firstpersonal pattern is the current basal profile pattern. The secondpersonal pattern will follow the first personal pattern and a “2” iconwill be displayed by the external infusion device at all times, on themain screen and the basal screen. The third pattern will follow thesecond pattern and display a “3” icon at all times. The patterns will bepresented to the user in a circular manner until the user selects dashesas the time for the next basal rate. The user will choose their personalpattern by selecting a 1, 2, or 3 in the setup II menu. The user willknow which pattern is current by looking for either a blank (i.e.,pattern 1 is on), a “2” icon (i.e., pattern 2 is on), or a “3” icon(i.e., pattern 3 is on).

Preferably, the user, or healthcare professional, may program twoseparate limits into the external infusion device 10. A maximum mealbolus can be set to limit the size of meal boluses. When setting a mealbolus the software will not allow the scrolling to exceed the maximum.There is also a maximum basal rate that limits the rate of profilesegments and the temporary basal rate. When setting profile segmentrates or a temporary basal rate, the software will not allow any valuesgreater than the maximum basal rate.

The meal bolus history function will allow the user to view the lasttwelve meal boluses in reverse-chronological order. The Up arrow key (▴)108 and the Down arrow key (▾) 112 are valid from the Select State. Themost recently delivered bolus will be displayed as bolus history 1.Older boluses will be histories 2 through 24. The display of the mostrecent bolus will show the word “LAST.” The display of the older boluseswill show the day of the week that they were delivered, for safetyreasons, the historical meal boluses may not be changed.

The external infusion device 10 will maintain a history of the dailytotals for the last 90 days. The user can only display the last 7 daysthrough the pump's display, (generally 90 days are accessible bydownloading only—although other numbers of days may be used). Thisdisplay is accessed as a Select State. The day for the total may bescrolled to view total history directly from the display state. Thetotal delivered Select State will have the day (displayed as “TODAY” fortoday's date or DayMonthYear [01SEP97] for any other day) blinking. Whenthe day is scrolled, the display shows the corresponding day's total.

Tile user will be able to review the last 200 events that occurred tothe pump. Generally, these may be reviewed on the LCD 28 of the externalinfusion device 10. Alternatively, the events are only available bydownloading the data through the transmitter/receiver 26 (for exampleusing IR serial communication) of the external infusion device 10.Typical types of events that can be received or downloaded are: timeadjustment; auto-off duration; maximum bolt's; maximum basal rate;insulin concentration; suspend on; suspend off; basal rate profile; tempbasal rate; battery removal and battery replacement, and carbohydrateestimator stored set values and history. The external infusion device 10may be capable of communicating via its bi-directional telemetry. Itwill be capable of sending data and receiving and executing commandsaccording to a well-defined protocol.

The LCD 28 of the external infusion device 10 introduces the capabilityto use icons for easier identification and use. For example, thefollowing icons are available: a clock alarm icon, a low battery alarmicon, a low insulin alarm icon, and one or more personal pattern icons.In alternative embodiments, more or fewer icons may be used. The use oficons makes an understanding of the display and alarm conditions easier,thus increasing safety and efficient use of the external infusion device10.

Alarms will be easily recognizable while providing the user with theinformation they need to make an informed decision. The alarms may bedisplayed on the LCD 28, provided audibly through the speaker 30 and/orusing the vibration alarm 16. An alert will sound when the plungerreaches the point where approximately 20 units of insulin (U-100)remain. In alternative embodiments, more or fewer remaining units may beused, and/or the units remaining may be programmable by the user orhealthcare professional. An icon indicating “Low Volume” will appear onthe main screen, and/or other alarms may be provided, until thecondition is corrected.

Preferred embodiments will include an alarm clock. The user willdetermine and set an amount of time, preferably from 30 minutes to 24hours, although longer or shorter periods may be set. The externalinfusion device 10 unit will provide an alarm and will prompt the userto repeat the same alarm frequency or cancel the alarm. The alarm willassist in warning the user on when to test blood glucose levels, injectinsulin or the like. Alternative embodiments may include multiple alarmsand different tones to permit more precise control and monitoring.

In preferred embodiments, all alarms will gradually escalate infrequency or volume so that the user can terminate them as soon as theyare noticed. In alternative embodiments, the alarms may change tones orintermittently stop to draw attention to the alarm condition. In furtheralternatives, the external infusion device 10 may use thetransmitter/receiver 26 to transmit the alarm to a remotely locateddevice, such as a Communication-Station, modem or the like to summonhelp.

In preferred embodiments, there is also a maximum number of externalinfusion device 10 strokes for the drive mechanism 32 that may occur inone hour based on the maximum basal rate and bolus amounts. The externalinfusion device 10 will sound (or vibrate) and the external infusiondevice 10 will not be able to deliver more than ((2.5 * maximumbolus)+maximum basal+1) strokes in one hour. Preferably, the externalinfusion device 110 will deliver medication in 0.1 units volumeincrements (although other increments may be used). The actual amount ofinsulin or medication in a given stroke depends on the insulin ormedication concentration, stroke length and delivery reservoir diameteror cross-sectional area. In preferred embodiments, the delivery ratesare scrolled by the amount of insulin per stroke. The rate deliverypattern will be calculated by dividing the number of strokes requiredfor the rate into 3600 (the number of seconds in one hour). The resultis the number of seconds between each stroke. The rate will be deliveredevenly over the hour, each stroke on a one-second boundary. Rates thatdo not divide evenly into 3600 will not have any accumulating error. Forexample, consider a rate of 3.0 units per hour and a concentration ofU-100. 3.0 U/hr at U-100 will require 30 strokes per hour. Thistranslates to a pump stroke every 3600/30=120 seconds, or one strokeevery two minutes. In alternative embodiments, the drive mechanism 32may provide for continuous flow rather than incremental or pulsed flowrates. Further alternatives may omit strokes and utilize hydraulics,pneumatics, step motors, continuous motors, or the like

The external infusion device 10 will support drug delivery in U-400,U-250, U-200, U-100, U-50 and U-40 concentrations of insulin. Inalternative embodiments, the external infusion device 10 will supportdrug delivery in insulin concentrations below U-40 and above U-400, suchas U-500 and U-1000. The amount of insulin delivered per pump strokedepends upon the concentration. If the concentration is changed, theconstant factors which convert pump strokes into units of insulin arechanged accordingly. Preferably, when a new concentration is selected,all settings except the time of day and day of week return to thefactory default settings. The default concentration is U-100. Inalternative embodiments, different default concentrations may be setbeing dependent on the type of fluid to be infused, and different or nosettings will return to the factory defaults. Preferred embodiments ofthe external infusion device 10 will utilize a conventional plastic(such as the MiniMed MMT-103) reservoir. Alternative embodiments may usereservoirs formed out of other materials, such as glass, metal or thelike; and the reservoir may be pre-filled or filled by the user prior touse in the external infusion device 10.

Preferred embodiments of the external infusion device 10 can be droppedin water without causing damage to the pump. (IEC601-1 IPX7 watertightstandard—although other levels of water resistance or standards may beused). The external infusion device 10 may be resilient to beingdropped, such as withstanding a 1500 g force with a 0.5 msec half-sinepulse duration (although other levels of impact resistance may be used).The infusion pump 10 will not be damaged by normal chemicals it mayencounter: soap, insulin, suntan lotion, alcohol, betadine, Cometcleanser, 409 cleaner, Windex, Joy dish soap, 25% bleach mixture.

Preferred embodiments will utilize a cylindrical Li/MnO₂ primarybattery.

Part Number Manufacturer PX28L (1406LC NEDA/ANSI: IEC) Duracell

Alternative embodiments may use multiple batteries, or batteries havingdifferent chemical compositions or characteristics. For instance,embodiments may use silver-oxide based batteries, such as Energizer 357batteries, mercury oxide, or other lithium chemistries. Furtherembodiments may include rechargeable batteries using either a DCpowerport, induction, solar cells, or the like, for recharging.

Preferably, the external infusion device 10 will report a low batterycondition at a battery voltage of 4.2 volts with a 1.0 milliamp load.The absolute maximum current that may be delivered by the battery willbe less than 60 milliamps for a maximum of 10 seconds. To maximizebattery life, each delivery of 0.1 unit of insulin will consume lessthan 0.025 millijoules of battery energy. The average continuous batterycurrent will not exceed 65 uA, excluding charging for insulin delivery.Preferably, the external infusion device 10 will indicate relativebattery longevity. This information can be conveyed in a concept similarto a cellular phone's battery status indicator. FIG. 13 illustratesexpected battery performance in days of operation versus units ofmedication delivered.

FIG. 14 illustrates a table of typical factory default values used by anexternal infusion device 10. Alternative embodiments, may use otherdefault values with the selection being dependent on the types ofmedication or fluid to be infused.

While the description above refers to particular embodiments of thepresent invention, it will be understood that many modifications may bemade without departing from the spirit thereof. The accompanying claimsare intended to cover such modifications as would fall within he truescope and spirit of the present invention.

The presently disclosed embodiments are therefore to be considered inall respects as illustrative and not restrictive, the scope of theinvention being indicated by the appended claims, rather than theforegoing description, and all changes which come within the meaning andrange of equivalency of the claims are therefore intended to be embracedtherein.

1. An ambulatory infusion system for infusion of a liquid into a body ofa user from a reservoir in a non-hospital environment, the ambulatoryinfusion system comprising: a glucose sensor to generate glucose sensorrelated information; an external infusion device; and a glucose meter togenerate glucose meter related information that is provided to theexternal infusion device; the external infusion device comprising: aninfusion device drive mechanism to operatively couple with the reservoirto infuse a liquid into a body, an infusion device housing adapted foruse on an exterior of the body, wherein the infusion device housing issized to contain at least a portion of the reservoir, wherein theinfusion device drive mechanism is at least partially contained withinthe infusion device housing, wherein the infusion device drive mechanismoperatively couples with the at least a portion of the reservoir withinthe infusion device housing, and wherein the infusion device housing iscapable of being concealed from view on an individual, an infusiondevice processor that uses the glucose meter related informationprovided from the glucose meter, an infusion device memory for storinginfusion device information related to the external infusion device, aninfusion device data receiving mechanism used in conjunction with theinfusion device processor to download the glucose sensor relatedinformation from the glucose sensor, and an indication device to displayat least some of the glucose sensor related information; and wherein theprocessor uses the downloaded glucose sensor related information fromthe glucose sensor, the glucose meter related information from theglucose meter and the infusion device information related to theexternal infusion device to assist the user in making therapy decisions.2. An ambulatory infusion system according to claim 1, wherein theglucose meter related information is provided manually to the externalinfusion device.
 3. An ambulatory infusion system according to claim 1,wherein the glucose meter related information is provided by a wirelesssignal received by the infusion data receiving mechanism.
 4. Anambulatory infusion system according to claim 3, wherein the wirelesssignal is an RF wireless signal.
 5. An ambulatory infusion systemaccording to claim 3, wherein the wireless signal is provided by aremote commander.
 6. An ambulatory infusion system according to claim 5,wherein the wireless signal is an RF wireless signal.
 7. An ambulatoryinfusion system according to claim 1, wherein the glucose sensor relatedinformation downloaded from the glucose sensor is provided via a glucosemonitor.
 8. An ambulatory infusion system according to claim 7, whereinthe glucose sensor related information is provided as a wireless signal.9. An ambulatory infusion system according to claim 8, wherein thewireless signal is an RF wireless signal.
 10. An ambulatory infusionsystem according to claim 1, wherein the glucose sensor relatedinformation downloaded from the glucose sensor is provided via a remotecommander.
 11. An ambulatory infusion system according to claim 10,wherein the glucose sensor related information is provided as a wirelesssignal.
 12. An ambulatory infusion system according to claim 1, whereinthe wireless signal is an RF wireless signal.
 13. An ambulatory infusionsystem according to claim 1, further including a PC, wherein theexternal infusion device further includes a transmitter, wherein theglucose sensor related information from the glucose sensor, the glucosemeter related information and the infusion device information related tothe external infusion device are downloaded to the PC to assist a healthcare professional in making therapy decisions.
 14. An ambulatoryinfusion system according to claim 1, wherein the downloaded glucosesensor related information from the glucose sensor, the glucose meterrelated information and the infusion device information related to theexternal infusion device are used to update the external infusion devicerelated information.
 15. An ambulatory infusion system according toclaim 1, wherein the liquid to be infused is insulin.
 16. An ambulatoryinfusion system according to claim 1, wherein the infusion deviceinformation related to the external infusion device includes insulinsensitivity.
 17. An ambulatory infusion system according to claim 16,wherein the infusion device memory stores the insulin sensitivityinformation.
 18. An ambulatory infusion system according to claim 1,wherein the infusion device information related to the external infusiondevice includes a duration factor used to determine a value of how longa previously infused amount of liquid will remain active in the body.19. An ambulatory infusion system according to claim 18, wherein theinfusion device memory stores the duration factor information.
 20. Anambulatory infusion system according to claim 1, wherein the infusiondevice information related to the external infusion device includestarget blood glucose levels.
 21. An ambulatory infusion system accordingto claim 20, wherein the infusion device memory stores the target bloodglucose information.